A Clinical Evaluation of AMJ-401
ConditionIschemic Heart Disease (IHD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be at least 18 years of age.
Subject or a legally authorized representative must be able to provide written Informed Consent prior to any study related procedure, per site requirements.
Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, acute myocardial infarction) suitable for elective PCI.
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Disqualifiers
Elective surgery planned within 12 months after the procedure that will require general anesthesia or discontinuing either aspirin or P2Y12 inhibitor.
Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, PLLA, PDLLA, platinum, lactic acid, and lactide) that cannot be adequately pre-medicated.
Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
Subject with known diagnosis of ST-elevation myocardial infarction (STEMI) within 72 hours of the index procedure.
Trial design
Design model
Single group
Treatments tested in this trial
AMJ-401
DevicePatients undergoing percutaneous coronary intervention of one or two de novo native coronary artery lesions with AMJ-401 in separate epicardial coronary vessels
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Intervention/TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute Strut Fracture
Acute strut fracture is assessed on a per-subject basis per final post-procedure OCT.
Time frame
6 months2
Strut Coverage
Strut coverage is assessed at 6-month OCT follow-up exam as the rate of uncovered struts on a per strut basis.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov